Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings

NCT ID: NCT07146659

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-05-31

Brief Summary

This is an observational prospective monocentric study which aims to compare operative hysteroscopies performed in the operating room under general or loco-regional anesthesia and those performed outside the operating room (outpatient operative hysteroscopy). The primary outcome is the success rate of the procedure. Secondary outcomes include postoperative pain, patient satisfaction, complications, and time to return to work.

Detailed Description

Operative hysteroscopy is a key technique for the treatment of intrauterine pathologies such as endometrial polyps, submucosal fibroids, retained products of conception. Traditionally, operative hysteroscopies are performed in the operating room under general or regional anesthesia, requiring either ambulatory or inpatient hospitalization.

In recent years, advances in hysteroscopic instrumentation and procedural techniques have made it possible to perform selected operative hysteroscopies in outpatient settings (consultation office) without general or regional anesthesia. Several studies have demonstrated the feasibility, safety, and effectiveness of outpatient operative hysteroscopy, with similar success rates and complication profiles compared to procedures performed in the operating room, although some studies reported higher levels of pain during outpatient procedures (1-3) . Furthermore, cost-effectiveness studies support outpatient procedures by highlighting reduced hospital resource utilization and shorter recovery times for patients (4-6).

The HOPE study aims to evaluate this practice locally at the Centre Hospitalier Intercommunal de Créteil. This prospective monocentric observational study will include approximately 400 patients over a two-year period (July 2025 - May 2027). The primary objective is to compare the success rates of operative hysteroscopies performed in the operating room versus those performed in an outpatient setting. Secondary objectives include assessment of perioperative and postoperative pain, patient satisfaction, complication rates, and the time to return to work.

Data will be collected from medical records and patient-reported outcomes using a satisfaction questionnaire. Inclusion of patients will follow the usual care pathway, without additional interventions or follow-up beyond standard clinical practice.

Conditions

Fibroid Uterus; Polyp Uterus; Retained Products of Conception

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Operative hysteroscopy in the operating room

Operative hysteroscopy in the operating room: Procedures performed under general or regional anesthesia in a surgical setting (either ambulatory or conventional hospitalization).

No interventions assigned to this group

Operative hysteroscopy in the outpatient setting

Operative hysteroscopy in the outpatient setting: Procedures performed in a consultation room without general or regional anesthesia, using local anesthesia if needed

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Women aged ≥ 18 years

-⁃ Undergoing operative hysteroscopy for intrauterine pathology

• Able to provid e informed non-opposition
• French-speaking

Exclusion Criteria

• Patients with contraindications to hysteroscopy
• Pregnancy
• Inability to complete follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHI Créteil - Gynécologie et obstétrique

Créteil, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Yann SALHI, MD

Role: CONTACT

yann.salhi@chicreteil.fr

0157022000 ext. 8456

Elie MOSNINO, MD

Role: CONTACT

elie.mosnino@gmail.com

Facility Contacts

Yann SALHI, MD

Role: primary

yann.salhi@chicreteil.fr

Elie MOSNINO, MD

Role: backup

elie.mosnino@gmail.com

Other Identifiers

HOPE

Identifier Type: -

Identifier Source: org_study_id